Zofran Birth Defect Lawyers

Representing Clients in Maryland, Washington, D.C. & Virginia

Zofran is a drug manufactured by GlaxoSmithKline that was approved by the
U.S. Food and Drug Administration to treat nausea and vomiting caused
by cancer chemotherapy, radiation therapy, and surgery. Its active ingredients
are ondansetron or ondansetron hydrochloride. Zofran is available as 4
mg and 8 mg tablets, 4 mg and 8 mg orally disintegrating tablets, and
oral solution (4 mg/5 mL). It is also available as an injection for intravenous
use (2 mg/mL).

There may be a link between pregnant women using Zofran and serious birth
defects. If you were prescribed Zofran to treat pregnancy-related nausea
and your child was born with birth defects, you may be entitled to financial
compensation. Contact the Zofran birth defect lawyers at Ashcraft &
Gerel to discuss your situation during a free consultation. We serve clients
in Maryland, Washington, D.C., and Virginia.

Off-Label Zofran Use & Consequences

Recently, the off-label use of Zofran to treat nausea and vomiting in pregnant
women is believed to have caused birth defects in the first trimester
of pregnancy in some cases.

The controversial use of Zofran by pregnant women has been the subject
of several studies in the last decade. While initial studies indicated
Zofran did not harm fetuses, later studies showed a significant risk increase
for birth defects. One study detected a twofold increase in congenital
heart defects associated with ondansetron during the first trimester of
pregnancy. Yet another study noted “a twofold increased risk for
cleft palate associated with ondansetron taken… in the first trimester
of pregnancy.”

According to the FDA, taking Zofran while pregnant can potentially lead
to serious birth defects, yet many doctors still frequently prescribe
it. Even worse, since morning sickness is most often associated with the
first trimester of pregnancy, women prescribed Zofran are taking it during
an infant’s most crucial development period.

The most common types of birth defects that can potentially come from Zofran include:

Musculoskeletal anomalies

Mouth deformities such as cleft palate

Heart defects

Fetal death

In July 2012, GlaxoSmithKline resolved a series of civil and criminal complaints
brought against it by the federal government. As stated in the Department
of Justice’s press release, “As part of a global resolution,
GSK has agreed to resolve its civil liability for the following alleged
conduct: (1) promoting drugs Paxil, Wellbutrin, Advair, Lamictal, and
Zofran for off label, non-covered uses and paying kickbacks to physicians
to prescribe these drugs as well as the drugs Imitrex, Lotronex, Flovent
and Valtrex.”

Protect Your Rights

Ashcraft & Gerel is investigating the safety of Zofran and possible
lawsuits against the manufacturers of Zofran. If you feel that you or
someone you know should be compensated for harm caused by use of Zofran,
please contact us to speak with an attorney today. All consultations are
free and completely confidential.

The information on this website is for general information purposes only.
Nothing on this site should be taken as legal advice for any individual
case or situation. This information is not intended to create, and receipt
or viewing does not constitute, an attorney-client relationship.